Development of the Alopecia Areata Patient Priority Outcomes Instrument: A Qualitative Study

• DOI: 10.1007/s13555-021-00508-w
• Publication Date: 2021-03-09T19:03:18Z
• Authors: Randall Winnette; Susan Martin; Nimanee Harris; Linda S. Deal
• Keywords: Debriefing; Sadness; Patient-reported outcome; Thematic Analysis

Although alopecia areata (AA) profoundly impacts patients' physical appearance, emotional state, and daily activities, no treatment approved for AA currently exists. Patient-reported outcome (PRO) instruments used to capture experiences do not meet the requirements support claims of benefit as described in US Food Drug Administration's 2009 PRO guidance. Our objective was explore consequences priority outcomes among individuals with develop a measure consistent regulatory that assesses these priorities represents clinical from patient perspective. Targeted literature instrument reviews informed an initial concept set. Concept elicitation interviews 20 adults confirmed relevance importance concepts, identified additional relevant consequence model. Thematic analysis yielded draft item pool, which evaluated through two iterative rounds cognitive debriefing 16 patients (9 adults; 7 adolescents). Hair loss primary AA. Patients emphasized need differentiate hair by location: scalp, eyebrows, eyelashes, body. Consequences include difficulty conducting particularly outdoor activities exercise, such sadness, frustration, negative self-image. Following interviews, 11 items were included form Alopecia Areata Patient Priority Outcome (AAPPO), assessing AA-related symptoms over past week. The AAPPO is novel, content-valid captures highest patients.